The present invention pertains to a process and apparatus for the transfer and sterilization of a solution. More particularly, it pertains to such a process and apparatus useful for the compounding of hyperalimentation solutions.
Hyperalimentation therapy is the intravenous feeding of, for example, a protein-carbohydrate mixture to a patient. It is used primarily to meet his protein and caloric requirements which are unable to be satisfied by oral feeding.
The protein may be in the form of free-amino acids or protein hydrolysate and the carbohydrate commonly used is dextrose. In addition to the protein and carbohydrate, vitamins (water-soluble and fat-soluble) and electrolytes can also be supplied in this therapy.
Each of these parenteral ingredients and the combination thereof are particularly susceptible to the growth of deleterious organisms and it is desirable that they be administered to the patient in a sterile condition. Thus, because these protein and carbohydrate solutions cannot be precompounded by the manufacturer, but must be combined at the time of their use, their compounding must be performed under sterile conditions to avoid organism growth.
A known apparatus and process for compounding hyperalimentation solutions utilizes a solution transfer system including a plastic receiving container and a Y-transfer set. A plastic container found to be particularly useful is one manufactured by Travenol Laboratories, Inc., of Deerfield, Illinois and marketed under the trademark VIAFLEX.RTM.. A known Y-transfer set includes two separate tubes, each having an end attached to a common juncture by which solutions delivered through the tubes will pass through the juncture into the attached plastic container. The other end of one tube of the set is attached to a protein holding container and of the other tube of the set to a carbohydrate holding container. The desired volume of each solution being transferred to the receiving container is controlled by a roller clamp placed on each tube. Each solution may be allowed to flow into the plastic container by gravity flow. However, it has been found to be useful to transfer same under the influence of a vacuum applied to the receiving container, which vacuum is created in a vacuum chamber into which the container is placed, such as the one manufactured by Travenol Laboratories, Inc., of Deerfield, Ill. and marketed under the trademark VIAVAC.RTM..
It has been known in the past that to maintain sterility during the compounding of hyperalimentation solutions, compounding should be perform under a laminar flow hood. Laminar flow hoods are useful for reducing the risk of airborne contamination of such solutions. These units operate by taking room air and passing it through a prefilter to remove gross contaminants, such as dust and lint. The air is then compressed and channeled through a bacterial retentive filter in the hood in a laminar flow fashion. The purified air flows out over the entire work surface of the hood in parallel lines at a uniform velocity. This type of filter is designed to remove essentially all bacteria from the air being filtered.
Compounding under a laminar flow hood aids in preventing airborne contamination, but it is relatively cumbersome and expensive. When using such a hood the operator might inadvertently perform the work at the edge or outside of the hood and not at least 6 inches within the hood to insure the benefits of the air being purified. Time must be taken and care must be exercised to maintain a direct open path between the filter and the compounding area. Solution bottles and other non-sterile objects cannot be placed at the back of the hood work area next to the filter because these objects could contaminate everything downstream and disrupt the laminar flow pattern of the purified air. Also, in using a laminar flow hook, it is necessary to routinely clean the work surface of the hood before any compounding is performed.
Therefore, it is the object of the present invention to provide a process and apparatus for transferring a solution from a holding container to a receiving container, such as a receiving bag of the type above identified, while also sterilizing such solution.
Another important object of the present invention is to provide a readily available process and apparatus for transferring and sterilizing the solution being transferred without the necessity of a laminar flow hood.
Other objects and advantages of present inventions will become apparent from the description of this invention that follows.